This invention relates to methods for the treatment of cocaine craving.
Cocaine is a highly addictive pyschostimulant that causes sensations of euphoria and craving, resulting in physiological as well as psychological damage. Although cocaine use leads to a multitude of physiological complications, its primary target of action is the central nervous system. Cocaine withdrawal following abstinence causes, among other symptoms, an intense craving for the abused drug, which in turn frequently results in the relapse into renewed drug use. Epidemiological studies point to a high incidence of multiple substance abuse among cocaine users, a finding that has significant societal and medical repercussions.
To date, approved pharmacotherapies for cocaine abuse and dependence have proven scarce despite the acute need for such therapies.
In general, the invention features methods for treating stimulant dependencies, such as cocaine craving, by administering a therapeutically-effective amount of a dopamine agonist, for example, pramipexole.
In one aspect, the invention provides a method of treating a patient (for example, a human) with a stimulant dependency by administering a therapeutically-effective amount of pramipexole to the patient. In preferred embodiments of this aspect, the stimulant dependency is a stimulant craving and the stimulant is cocaine.
In a related aspect, the invention provides a method of treating a human diagnosed with cocaine craving by administering a therapeutically-effective amount of pramipexole to the human.
In preferred embodiments of both of the above aspects of the invention, the method further includes administering a therapeutically-effective amount of an antidepressant or an anticonvulsant, for example, lamotrigine.
By xe2x80x9ctreatingxe2x80x9d is meant the medical management of a patient with the intent that a cure, amelioration, or prevention of a dependency or a relapse or associated disease, pathological condition, or disorder will result. This term includes active treatment, that is, treatment directed specifically toward improvement of the dependency or associated cure of a disease, pathological condition, or disorder, and also includes causal treatment, that is, treatment directed toward removal of the cause of the dependency or associated disease, pathological condition, or disorder. In addition, this term includes palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the dependency, disease, pathological condition, or disorder; preventive treatment, that is, treatment directed to prevention of the dependency or associated disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the dependency or associated disease, pathological condition, or disorder. The term xe2x80x9ctreatingxe2x80x9d also includes symptomatic treatment, that is, treatment directed toward constitutional symptoms of the dependency or an associated disease, pathological condition, or disorder.
By xe2x80x9cstimulantxe2x80x9d is meant any substance that temporarily increases functional activity, and preferably cardiac, respiratory, cerebral, nervous, vascular, motor, or vasomotor functional activity. Preferred stimulants include, without limitation, cocaine, amphetamines, methamphetamine, and methylphenidate.
By xe2x80x9ctherapeutically-effective amountxe2x80x9d is meant an amount of a pramipexole compound sufficient to produce a healing, curative, or ameliorative effect either in the treatment of a stimulant dependency or in the symptoms of a stimulant dependency, for example, cocaine craving.
By xe2x80x9cdependencyxe2x80x9d is meant any form of behavior that indicates an altered or reduced ability to make decisions resulting, at least in part, from the use of stimulants. Representative forms of dependency behavior may take the form of antisocial, inappropriate, or illegal behavior and include those behaviors directed at the desire, planning, acquiring, and use of stimulants. This term also includes the psychic craving for a drug that may or may not be accompanied by a physiological dependency, as well as a state in which there is a compulsion to take a drug, either continuously or periodically, in order to experience its psychic effects or to avoid the discomfort of its absence. Forms of xe2x80x9cdependencyxe2x80x9d include habituation, that is, an emotional or psychological dependence on a compound to obtain relief from tension and emotional discomfort, as well as physical or physiological dependence, that is, use of a compound to prevent withdrawal symptoms.
By xe2x80x9ccravingxe2x80x9d is meant a behavior that reflects a consuming desire, longing, or yearning for a stimulant. This term may refer to aspects of behaviors that are components of a dependency.
The present invention provides a number of advantages. Importantly, it provides one of the first therapeutics for the treatment of stimulant cravings (such as cocaine craving). In addition, the pramipexole utilized herein is non-toxic, is pharmocokinetically understood, and is known to be well tolerated by humans, as is evidenced by its approval for the treatment of Parkinson""s Disease.